A Study to Learn About the Study Medicine (Maplirpacept) in People With Advanced Non-Hodgkin Lymphoma or Multiple Myeloma in China

NCT05896774 | Completed Phase 1

• 1 other identifier: C4971010
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to learn about the safety and what the body does to the medicine (Maplirpacept) when taken for the treatment of non-Hodgkin lymphoma or multiple myeloma. Non-Hodgkin lymphoma is any of a large group of cancers of lymphocytes (white blood cells). Multiple myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). This study is seeking participants who:

• have non-Hodgkin lymphoma or multiple myeloma.
• have worsened with (or lack of improvement to) a standard treatment taken before.
• have relatively normal functioning organs. All participants in this study will receive Maplirpacept as an intravenous (IV) infusion (given directly into a vein) at the study clinic every week. Participants will continue to receive Maplirpacept until:
• the cancer worsens.
• some serious side effects show up.
• the participants do not wish to take the study medicine any more. The experiences of the people receiving the study medicine will be collected. This will help to understand if the study medicine Maplirpacept, is safe and can be given to Chinese people.

Conditions

Non-Hodgkin Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Dose-Limiting Toxicity (DLT)

  Part A only. To characterize the dose limiting toxicities (DLTs) of Maplirpacept.

  Cycle 1：up to 21 days

• Single-dose Cmax

  Maximum Observed Plasma Concentration

  0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

• Single-dose AUClast

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

• Single-dose AUCtau

  Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 1 week.

  0, 1, 2, 4, 24, 72 hours post-dose up to Day 8

Secondary Outcomes (21)

• Number of Participants With Adverse Events (AEs) by type, frequency, severity (as graded by NCI CTCAE verision 5.0), timing, seriousness and relationship to study treatment

  Baseline up to 28 days after the last dose of study drug

• Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

  Baseline up to 28 days after the last dose of study drug

• Single-dose Tmax (Time to Reach Maximum Observed Plasma Concentration)

  0, 1, 2, 4, 24, 72 hours post-dose up to Day8

• Multiple-dose Cmax (Maximum Observed Plasma Concentration)

  Through study completion, up to 18 months

• Multiple-dose Ctrough (trough concentration)

  Through study completion, up to 18 months

Study Arms (1)

Maplirpacept (PF-07901801)

EXPERIMENTAL

single arm study

Drug: Maplirpacept

Interventions

Maplirpacept DRUG

Study drug will be administered intravenously with adjustment for body weight weekly over 28-day cycles.

Also known as: PF-07901801, TTI-622

Maplirpacept (PF-07901801)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed relapsed/refractory non-Hodgkin lymphoma without other effective therapeutic option. Or relapsed/refractory multiple myeloma exposed to therapies including PI, IMiD and anti-CD38 antibody.
• With measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
• Adequate organ functions (including hematologic status, coagulation, hepatic, and renal)

You may not qualify if:

• Active plasma cell leukemia, or POEMS syndrome.
• Known, current central nervous system disease involvement.
• Significant cardiovascular disease.
• Chronic use of systemic corticosteroids of more than 20 mg/day of prednisone or equivalent.
• Radiation therapy within 14 days of study treatment administration.
• Hematopoietic stem cell transplant within 90 days before the planned start of study treatment or participants with active GVHD disease.
• Use of any anticancer drug within 14 days before planned start of study treatment.
• Prior anti-CD47 or anti-SIRP alpha therapy.
• Participation in other studies involving investigational drug(s) or vaccines within 4 weeks from the last dose
• Known active, uncontrolled bacterial, fungal, or viral infection.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: June 28, 2023
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)